(131 days)
Interlude rolled tampons in plastic applicator are inserted into the vagina and used to absorb menstrual or other vaginal discharge.
Interlude rolled tampons in plastic applicator are menstrual tampons used to absorb menstrual fluid. These tampons will be provided with 3 absorbencies - Regular, Super and Super Plus. These Tampons are rolled and made from organic cotton and polymeric overwrap in which a cotton cord is inserted. The applicator tubes are made of plant-based polyethylene and include a cylindrical barrel with finger grip and a one-piece plunger. The assembled tampon with applicator is wrapped in a printed PE wrapper.
This document describes the premarket notification (510(k)) for the Interlude Rolled Tampons in Plastic Applicator. It outlines the device, its intended use, comparison to a predicate device, and performance testing conducted.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Performance Characteristic) | Reported Device Performance (K191431) |
|---|---|
| Dimensions | Met |
| Absorbency range (Syngyna Absorbency) | Regular: 6.0 - 9.0 grams |
| Super: 9.0 - 12.0 grams | |
| Super Plus: 12.0 - 15.0 grams | |
| Chemical residues | Met |
| Withdrawal cord strength | Met |
| Fiber shedding | Met |
| Tampon integrity | Met |
| Biocompatibility in accordance with ISO 10993 standards: | |
| Cytotoxicity (MEM Elution Test) | Met requirements of ISO 10993-5:2009 |
| Sensitization (Guinea Pig Maximization Test) | Met requirements of ISO 10993-10:2010 (R) 2014 |
| Irritation (Vaginal Irritation Test) | Met requirements of ISO 10993-10:2010 (R) 2014 |
| Acute Systemic Toxicity | Met requirements of ISO 10993-11:2006 |
| Microbiology Testing (does not enhance growth of): | |
| Staphylococcus aureus | Demonstrated not to enhance growth |
| Toxic Shock Syndrome Toxin-1 (TSST-1) production | Demonstrated not to increase production |
| Alteration of normal vaginal microflora | Demonstrated not to alter growth |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific test (e.g., dimensions, absorbency, chemical residues, biocompatibility, microbiology). However, it implies that the testing was conducted on samples of the "subject tampons and applicators." The data provenance is not specified regarding country of origin or whether it was retrospective or prospective, but it refers to testing performed on the final device product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The testing appears to be objective, lab-based performance and biocompatibility testing rather than expert-driven ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. The tests are based on objective measurements against established standards and criteria, not on expert adjudication of interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a medical device (tampon) and not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device (tampon) and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance testing is based on:
- Established standards and guidance documents: Specifically, the "2005 FDA guidance document 'Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff'" for performance characteristics and the "FDA guidance document 'Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process' issued in 2016 and ISO 10993 standards" for biocompatibility.
- Objective laboratory measurements: For dimensions, absorbency, chemical residues, withdrawal cord strength, fiber shedding, tampon integrity, and microbiological growth.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, this is a physical medical device.
§ 884.5470 Unscented menstrual tampon.
(a)
Identification. An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).